REJOICE/DS6000-126

REJOICE-PanTumor01: A Phase 2, Multicenter, Open-Label, Pan-Tumor Trial to Evaluate Efficacy and Safety of Raludotatug Deruxtecan (R-DXd) in Participants With Advanced/Metastatic Solid Tumors

Open
Grade
High grade, Low grade, Other / unknown
Prior lines
1, 2, 3
Histology
Serous, Carcinocarcoma
Phase
II
IMP
Raludotatug Deruxtecan (R-DXd)
principal investigator
Prof. Dr. Toon Van Gorp

Treatment

  • R-DXd administered intravenously Q3W

     

Treatment duration

The treatment can continue until disease progression, unacceptable toxicity or withdrawal of consent.

Eligibility

Main inclusion criteria:

  • Pathologically or cytologically documented endometrial cancer (carcinoma of any histological subtype or carcinosarcoma), irrespective of MSI or mismatch repair status.
  • Documented disease progression after having received ≥1 line of therapy (no more than 3), including platinum based chemotherapy and an anti-PD-1 therapy containing regimen (combined or sequential) in the advanced/metastatic setting.
  • Participants must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pre-treatment biopsy from a primary and/or metastatic lesion.
  • Has at least 1 measurable lesion according to RECIST version 1.1 per investigator assessment.

 

Main exclusion criteria:

  • Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
  • Prior exposure to other CDH6-targeted agents or an ADC that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, trastuzumab deruxtecan, datopotamab deruxtecan).

Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06660654). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.

Contact

In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be